a phase iii study of skb264 for egfr mutant nsclc patients

Conditions: Non-small Cell Lung Cancer

Summary: this is a randomized, open-label, multicenter phase 3 clinical study to evaluate skb264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous nsclc with egfr mutation who have failed to egfr-tki therapy.

this is a randomized, open-label, multicenter phase 3 clinical study to evaluate skb264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous nsclc with egfr mutation who have failed to egfr-tki therapy. the primary objective is to compare the efficacy and safety of skb264 monotherapy versus pemetrexed in combination with platinum in patients with locally advanced or metastatic non-squamous nsclc with egfr mutation who have failed to egfr-tki therapy.

Eligibility criteria:
inclusion criteria: 1. males or females aged ≥18 to ≤75 years at the time of signing the icf; 2. histologically or cytologically confirmed non-squamous nsclc and locally advanced (stage iiib/iiic) or metastatic (stage iv) non-squamous nsclc not amenable to radical surgery and/or radical concurrent/sequential chemoradiotherapy; 3. egfr-sensitive mutations; 4. failure of prior egfr-tki therapy; 5. at least one measurable target lesion per recist 1.1 as assessed by the investigator; 6. eastern cooperative oncology group (ecog) performance status of 0 or 1; 7. expected survival ≥12 weeks; 8. adequate organ and bone marrow function; 9. female subjects of childbearing potential and male subjects with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose; 10. subjects voluntarily participate in the study, sign the icf, and will be able to comply with the protocol-specified visits and relevant procedures exclusion criteria: 1. histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%; 2. other malignancies within 3 years prior to the first dose; 3. history of (noninfectious) interstitial lung disease (ild)/noninfectious pneumonitis requiring steroid therapy and current ild/noninfectious pneumonitis; 4. subjects with active chronic inflammatory bowel disease, gi tract obstruction, severe ulcers, perforation gastrointestinal, abdominal abscess, or acute gi tract bleed; 5. toxicities from prior anti-tumor therapy not recovering to ≤ grade 1 (per nci ctcae 5.0) or to the level specified in the eligibility criteria; 6. subjects with human immunodeficiency virus (hiv) test positive or history of acquired immunodeficiency syndrome (aids); known active syphilis infection; 7. prior trop2-targeted therapy; 8. prior treatment with any drug therapy targeting topoisomerase i inhibitor, including antibody-drug conjugates (adcs); 9. major surgery within 4 weeks prior to the first dose or expected to require major surgery during the study; 10. subjects who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study; 11. pregnant or lactating women;